Efficacy and safety of a fixed combination of benzoyl peroxide 4% and niacinamide 4% in a polyvinyl alcohol and perfluoro-ether polymer-based cream for the treatment of mild to moderate inflammatory rosacea

Efficacy and safety of a fixed combination of benzoyl peroxide 4% and niacinamide 4% in a polyvinyl alcohol and perfluoro-ether polymer-based cream for the treatment of mild to moderate inflammatory rosacea: a prospective assessor-blinded pilot trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN17674262

Enrollment

Registered

2025-12-02

Start date

2025-01-27

Completion date

Unknown

Last updated

2026-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mild to moderate inflammatory rosacea Skin and Connective Tissue Diseases

Interventions

The patients were instructed to apply 0.25 ml of the tested product to the affected facial areas once daily at bedtime for 8 weeks. A mild, fragrance-free, hypoallergenic facial fluid cleanser, along

Eligibility

Sex/Gender

All

Age

26 Years to 67 Years

Inclusion criteria

Inclusion criteria: 1. Diagnosis of mild to moderate inflammatory rosacea (= 5 papulopustular lesions), according to the Global ROSacea Consensus (ROSCO) panel (2019) 2. Wash-out period of at least 15 or 30 days for previous topical or systemic pharmacological agents for rosacea, respectively

Exclusion criteria

Exclusion criteria: 1. Concomitant other inflammatory facial dermatoses 2. Known hypersensitivity or allergies to any components of the tested formulation 3. Pregnancy or breastfeeding

Design outcomes

Primary

Measure	Time frame
1. Overall treatment efficacy measured using IGA score at baseline, T1 (4 weeks), and T2 (8 weeks) 2. Erythema measured using a 4-point scale (from 0 = none, to 3 = severe erythema) at baseline, T1 (4 weeks), and T2 (8 weeks)	—

Secondary

Measure	Time frame
1. The evolution in the number of papule and pustular lesions measured by counting the number of inflammatory lesions at baseline, T1, and T2 2. Instrumental evaluation of erythema performed using VISIA-CR imaging at baseline, T1, and T2 3. Local tolerability of the product evaluated using a tolerability score (from score 0= very well tolerated, no pain/burning feeling and dryness feeling; to score 4= very intense pain/burning/dryness feeling) at T1 and T2	—

Measure

Time frame

1. The evolution in the number of papule and pustular lesions measured by counting the number of inflammatory lesions at baseline, T1, and T2 2. Instrumental evaluation of erythema performed using VISIA-CR imaging at baseline, T1, and T2 3. Local tolerability of the product evaluated using a tolerability score (from score 0= very well tolerated, no pain/burning feeling and dryness feeling; to score 4= very intense pain/burning/dryness feeling) at T1 and T2

—

Countries

Italy

Contacts

Public ContactMassimo Milani

massimo.milani@difacooper.com+39 (0)280030205

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026